Study investigating the effect of degarelix on the heart

• Research type

  Research Study

• Full title

  A three-way crossover study investigating the effect of degarelix on the QT/QTc interval in healthy men

• IRAS ID

  87957

• Contact name

  Ashley Brooks

• Sponsor organisation

  Ferring Pharmaceuticals Ltd

• Eudract number

  2011-000100-18

• Research summary

  The purpose of this study is to determine if degarelix increases the QT/QTc interval on the ECGs of healthy volunteers. The QT/QTc interval is a measurement taken from an ECG which represents the point in the cardiac cycle where the heart is refilling between beats. It is important to assess a drug’s effect on the QT/QTc interval as patients with increased QT/QTc intervals may be at increased risk of developing abnormal heart rhythms (in particular a rhythm called Ventricular Tachycardia) which can be life threatening. Degarelix is a gonadotrophin-releasing hormone (GnRH) antagonist intended as a treatment for prostate cancer. Moxifloxacin is an antibiotic that acts as a positive control in this study (it is known to prolong QT/QTc intervals). Up to 80 subjects will be enrolled. Each subject will take part in three residential sessions which will each last approximately 4 days. There will be a washout period of seven to ten days between dosing at each residential session. In each residential session subjects will receive one of the following treatment regimens: 1, Degarelix 2.8mg in 5% glucose administered as a 60 minute intravenous infusion.2, Degarelix placebo (5% glucose) administered as a 60 minute intravenous infusion. 3, Single oral tablet of 400mg moxifloxacin hydrochloride. Each subject will receive each treatment once. Treatment allocation will be randomly assigned in order to reduce bias. At each residential session intensive ECG sampling will be performed on Day 1. Changes in ECG parameters from baseline will be calculated at each residential session and compared. There will be a washout period of 7-10 days between each residential session. All subjects will be healthy male volunteers aged between 18 and 45 years of age. All doses will be administered while subjects are resident in the unit. Post study safety assessments will be performed at a follow-up visit approximately 7 to 10 days after the last residential session.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0151

• Date of REC Opinion

  27 Sep 2011

• REC opinion

  Favourable Opinion